(1) Field of the Invention
This invention relates to an endoscopic tissue-fastening device and related fastener and methods for use, and more particularly, a device which allows segments of the fastener to be independently attached to the tissue
(2) Description of Related Art
Endoscopic stapling devices have been created in which a staple or other fastening device stored in a tubular member is pushed from the remote end of the tubular member to seal a gap or hole in flesh. U.S. Pat. No. 7,175,648 to Nakao, U.S. Pat. No. 5,222,961 to Nakao et al., U.S. Pat. No. 7,063,715 to Onuki et al., U.S. Pat. No. 6,872,214 to Sonnenschein et al., U.S. Pat. No. 5,782,397 to Koukline, and U.S. Pat. No. 6,626,916 to Yeung et al.
However, these devices initially puncture or grasp the tissue to be fastened in the same “forward” direction as the extension of the tubular member or other extension device, that is, in the direction from the proximate end of the tubular member which allows for the devices to be held to the remote end of the tubular member where the staples or other fasteners are dispensed. Thus, the tissue acted upon is the tissue directly in front of the remote end of the tubular member. When the tubular member in these devices extend towards the exterior of the stomach or other lumen-containing organ from the interior of the stomach or the other lumen-containing organ, these portions of the staple, or a grasping device, grasp or puncture the interior, mucosal/submucosal layer of the stomach or the interior layer of the other lumen-containing organ.
This disclosure identifies special problems that are presented by the use of these devices on the wall of the stomach. For example, there is a risk of grasping or puncturing organs on the exterior of the intended organ. The interior mucosal/submucosal layer of the stomach is, by comparison to the exterior muscularis/serosal layer of the stomach, a very thick, loose, and slippery layer. The mucosal layer is difficult to grasp directly, and an attempt to puncture it from the interior of the stomach creates the risk of puncturing organs on the other side. These issues can extend surgery time and create a health risk to the patient. However, the exterior muscularis/serosal layer is much easier to grasp and puncturing it from the exterior of the stomach is much safer.
Moreover, these devices simultaneously expose, and simultaneously fasten tissue with, two opposite segments of the fastener. This does not allow for separate exposure and fastening with each of the two opposite segments. As a result, no fastening may occur until after the tissue on each side of the wound is moved near the tissue on the other side of the wound, and a sole tissue-embedded segment may not be used to reposition the tissue in preparation for embedding of the other segment.
Therefore, a need exists for a new and improved stapling device and related staple, for endoscopic stomach wall stapling or other hollow organ wall stapling or other uses, that provides for initial grasping or puncturing to occur on the exterior layer, in a backwards direction, and a need also exists for a new and improved stapling device that allows for independent exposure and embedding of each of two segments of the fastener.